AstigmatismNCT03202485
Comparison Between TICL and ICL+AK for High Myopic Astigmatism
A study testing Toric Implantable Collamer Lens and ICL + Astigmatic keratotomy in people with Astigmatism and High Myopia, run by Wenzhou Medical University.
Trial summary
To compare the outcomes of a toric Implantable Collamer Lens (ICL) and a spherical Implantable Collamer Lens combined with astigmatic keratotomy (AK) in the correction of high myopic astigmatism. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Astigmatism, High Myopia
- What is being tested?
- Toric Implantable Collamer Lens and ICL + Astigmatic keratotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 3 Mar 2014to 1 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age ranged from 18 to 40 years,
- myopia greater than -8.00 diopters (D), and refractive cylinder in the range of 1.50D to 5.50D,
- for the patients who were planned to undergo AK+ICL implantation, the axial difference between the corneal astigmatism and the manifest refractive astigmatism was less than 10 degree,
- a stable refractive error during the previous 2 years,
- anterior chamber depth more than 2.8 mm,
- endothelial cell density (ECD) more than 2500 cells/mm2, and
- scotopic pupillary diameter less than 7 mm.
Who cannot join
- subjects had significant irregular astigmatism, corneal pathological changes, glaucoma, ocular inflammation, or previous ocular trauma or surgery.
About this study
Official title: Comparison Between Toric and Spherical Implantable Collamer Lens Combined With Astigmatic Keratotomy for High Myopic Astigmatism
To compare the outcomes of a toric Implantable Collamer Lens (ICL) and a spherical Implantable Collamer Lens combined with astigmatic keratotomy (AK) in the correction of high myopic astigmatism.
- Conditions
- Astigmatism, High Myopia
- Being tested
- Toric Implantable Collamer Lens, ICL + Astigmatic keratotomy
- Keywords
- astigmatism, high myopia, phakic intraocular lens, astigmatic keratotomy, toric
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toric Implantable Collamer LensDevice
uses Toric Implantable Collamer Lens implantation to correct the high myopic astigmatism.
ICL + Astigmatic keratotomyDevice
uses Implantable Collamer Lens implantation combined with Astigmatic keratotomy to correct the high myopic astigmatism
| Study group | Role | What they receive |
|---|---|---|
| Toric Implantable Collamer Lens | Active comparator | Subjects in this group will implant Toric Implantable Collamer Lens for high myopic astigmatism Receives: Device: Toric Implantable Collamer Lens |
| ICL+ Astigmatic keratotomy | Experimental | Subjects in this group will implant Implantable Collamer Lens and combined with astigmatic keratotomy for high myopic astigmatism Receives: Device: ICL + Astigmatic keratotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Visual Acuity (UCVA) at distance
measured at 5 meter
Measured: 2 years after surgery
astigmatism
astigmatism getting from subjective refraction
Measured: 2 years after surgery
Secondary outcomes (4)
Best Corrected Visual Acuity (BCVA) at distance
subjective refraction
Measured: 2 years after surgery
Spherical Equivalent (SE)
subjective refraction
Measured: 2 years after surgery
mean postoperative BCVA/mean preoperative BCVA
safety index
Measured: 2 years after surgery
mean postoperative UCVA/mean preoperative BCVA
efficacy index
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start3 Mar 2014
- Primary completion2 Mar 2015
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AstigmatismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective comparative case series
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A-Yong Yu, Wenzhou Medical University
- Investigators
- AYong Yu, MD.PhD., Principal investigator, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202485
- Sponsor's protocol ID
- TICL compare with ICL+AK
- Status last verified
- Jun 2017
- First submitted
- 22 Jun 2017
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zheng LY, Zhu SQ, Su YF, Zou HY, Wang QM, Yu AY. Comparison between toric and spherical phakic intraocular lenses combined with astigmatic keratotomy for high myopic astigmatism. Eye Vis (Lond). 2017 Aug 18;4:20. doi: 10.1186/s40662-017-0085-7. eCollection 2017.
PubMed 28828390
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Toric and Spherical Implantable Collamer Lens Combined With Astigmatic Keratotomy for High Myopic Astigmatism
- ClinicalTrials.gov ID
- NCT03202485
- Acronym / sponsor ID
- TICL compare with ICL+AK
- Conditions
- Astigmatism, High Myopia
- Keywords
- astigmatism, high myopia, phakic intraocular lens, astigmatic keratotomy, toric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 3 Mar 2014 (actual)
- Primary completion
- 2 Mar 2015 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the outcomes of a toric Implantable Collamer Lens (ICL) and a spherical Implantable Collamer Lens combined with astigmatic keratotomy (AK) in the correction of high myopic astigmatism.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective comparative case series
| Arm | Type | Receives |
|---|---|---|
| Toric Implantable Collamer Lens | Active comparator | Device: Toric Implantable Collamer LensSubjects in this group will implant Toric Implantable Collamer Lens for high myopic astigmatism |
| ICL+ Astigmatic keratotomy | Experimental | Device: ICL + Astigmatic keratotomySubjects in this group will implant Implantable Collamer Lens and combined with astigmatic keratotomy for high myopic astigmatism |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age ranged from 18 to 40 years,
- myopia greater than -8.00 diopters (D), and refractive cylinder in the range of 1.50D to 5.50D,
- for the patients who were planned to undergo AK+ICL implantation, the axial difference between the corneal astigmatism and the manifest refractive astigmatism was less than 10 degree,
- a stable refractive error during the previous 2 years,
- anterior chamber depth more than 2.8 mm,
Key exclusion criteria (1 listed)
- subjects had significant irregular astigmatism, corneal pathological changes, glaucoma, ocular inflammation, or previous ocular trauma or surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toric Implantable Collamer Lensuses Toric Implantable Collamer Lens implantation to correct the high myopic astigmatism. | Device | Toric Implantable Collamer Lens |
| ICL + Astigmatic keratotomyuses Implantable Collamer Lens implantation combined with Astigmatic keratotomy to correct the high myopic astigmatism | Device | ICL+ Astigmatic keratotomy |
Primary outcome
Uncorrected Visual Acuity (UCVA) at distance
Time frame: 2 years after surgery
measured at 5 meter
astigmatism
Time frame: 2 years after surgery
astigmatism getting from subjective refraction
4 secondary outcomes
Best Corrected Visual Acuity (BCVA) at distance
Time frame: 2 years after surgery
Spherical Equivalent (SE)
Time frame: 2 years after surgery
mean postoperative BCVA/mean preoperative BCVA
Time frame: 2 years after surgery
mean postoperative UCVA/mean preoperative BCVA
Time frame: 2 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Derived from this study: PubMed 28828390Zheng LY, Zhu SQ, Su YF, Zou HY, Wang QM, Yu AY. Comparison between toric and spherical phakic intraocular lenses combined with astigmatic keratotomy for high myopic astigmatism. Eye Vis (Lond). 2017 Aug 18;4:20. doi: 10.1186/s40662-017-0085-7. eCollection 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AYong Yu, MD.PhD. principal investigator
Wenzhou Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Toric Implantable Collamer Lens and ICL + Astigmatic keratotomy in people with Astigmatism and High Myopia, run by Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected Visual Acuity (UCVA) at distance (time frame: 2 years after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03202485, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.